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Hyperglycemia in Neurosurgery

Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05236751
Enrollment
52
Registered
2022-02-11
Start date
2021-05-24
Completion date
2023-05-13
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia, Postoperative Infection

Keywords

Intraoperative hyperglycemia, Postoperative infection, Neurosurgical patient, Open surgical intracranial intervention, Endoscopic intracranial intervention

Brief summary

Poor glycemic control is recognized as a risk factor for postoperative infection. For the neurosurgical patient, postoperative infection can lead to devastating complications such as meningitis, encephalitis and death. Neurosurgical patients often receive high doses of medications that increase blood glucose levels such as steroids, placing them at a potentially higher risk for postoperative infection. The purpose of this multisite observational study is to assess the impact of severe intraoperative hyperglycemia as a risk factor for postoperative infection in the neurosurgical patient.

Detailed description

This is a multisite \[3 locations\] prospective observational study of adult patients (18-89 years old) scheduled for elective intracranial (open or endoscopic) procedures that require general anesthesia and a hospital stay of at least 1 day after the surgery. All sites will follow the standard of care clinical protocol for glycemic management that was developed at Boston Medical Center (BMC). Laboratory tests will be collected at the discretion of the primary clinician. This observational study does not require any change to routine clinical practice. The following perioperative data (timeframe between Pre-Procedure Clinic visit through Post-Anesthesia Care Unit discharge): blood glucose measurements, total insulin dose, total dexamethasone dose, estimated intraoperative blood loss, antibiotic prophylaxis regimen. The patient's electronic medical records data will be reviewed 7 days after the neurosurgical procedure to abstract all available culture data (blood, urine, sputum, CSF), available treatment regimen data prescribed for infection (antibiotics), complications from hyperglycemia (diabetic ketoacidosis, hyperglycemic nonketotic coma) or insulin therapy (hypoglycemia episodes). Intensive care unit (ICU) and hospital length of stay will also be obtained form the medical records. The investigators anticipate finding four groups of patients with regards to intraoperative blood glucose levels and management: 1) patients with no episodes of severe intraoperative hyperglycemia, 2) patients with intraoperative hyperglycemia who received insulin treatment, 3) patients with intraoperative hyperglycemia who did not receive insulin treatment and 4) patients with no available laboratory data.

Interventions

None listed

Sponsors

University of Roma La Sapienza
CollaboratorOTHER
Burdenko Neurosurgery Institute
CollaboratorOTHER
Boston Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult patients scheduled for elective intracranial (open surgical or endoscopic) intervention * General anesthesia * Hospital stay of at least 1 day post-procedure

Exclusion criteria

* Diagnosis of infection (local or systemic) in preoperative period * Emergency procedures

Design outcomes

Primary

MeasureTime frameDescription
Postoperative infection7 days after surgeryProportion of patients diagnosed with infection (such as wound, pulmonary, urological, blood) in the postoperative period

Secondary

MeasureTime frameDescription
Intraoperative glucose level in whole bloodbefore incision and at the end of surgeryTwice intraoperatively abstracted from electronic medical records
Intraoperative dose of insulinDuring surgical procedureAbstracted from electronic medical records
Dosages and regimen of dexamethasone in the perioperative periodpreoperative clinic visit to within 7 days of surgeryAbstracted from electronic medical records
Antibiotic prophylaxis schemePreoperativelyTypes of antibiotics administered preoperatively abstracted from electronic medical records.
Duration of stay in ICU in hours30 daysAbstracted from electronic medical records
Duration of stay in hospital in days30 daysAbstracted from electronic medical records
Perioperative complicationspreoperative clinic visit to within 7 days of surgeryPerioperative complications (such as episodes of hemodynamic instability, blood loss) abstracted from electronic medical records

Countries

Italy, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026